Insmed Receives Positive EMA Committee Advice for Brensocatib (BRINSUPRI) for Non-Fibrocystic Bronchiectasis
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BRINSUPRI (brensocatib) has received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of non-fibrocystic bronchiectasis (NCFB). This recommendation paves the way for potential approval and access to the medication for eligible patients across the European Union as early as 2026. The drug, already approved in the US and Japan, offers a new treatment option for a debilitating lung disease.
What is Non-Fibrocystic Bronchiectasis (NCFB)?
Non-fibrocystic bronchiectasis (NCFB) is a chronic lung condition characterized by permanent widening and damage to the airways, leading to a buildup of mucus and recurrent infections. https://www.nhlbi.nih.gov/health/bronchiectasis This results in symptoms like chronic cough, shortness of breath, and fatigue, significantly impacting quality of life. Unlike cystic fibrosis-related bronchiectasis, NCFB doesn’t stem from a genetic defect in mucus production but can be caused by various factors including infections, immune deficiencies, and airway obstructions.
Understanding Brensocatib (BRINSUPRI)
Brensocatib, marketed as BRINSUPRI, is an orally administered, once-daily medication. It functions as a reversible inhibitor of dipeptidyl peptidase 1 (DPP1). https://www.insmed.com/pipeline/brinsupri-brensocatib/ DPP1 plays a role in activating enzymes (neutrophil serine proteases) released by neutrophils, a type of white blood cell. In NCFB, these enzymes contribute to chronic airway inflammation and lung damage. by inhibiting DPP1, brensocatib aims to reduce this inflammation.
Key Features of BRINSUPRI:
* Mechanism of Action: Inhibits DPP1, reducing neutrophil-mediated airway inflammation.
* Governance: Oral, once-daily tablet.
* Dosage: Available in 10mg and 25mg tablets.
* Approved Indication (EU): Treatment of NCFB in patients aged 12 years and older with two or more flare-ups in the previous 12 months.
* Approved Indication (US): Treatment of NCFB in adult and pediatric patients 12 years of age and older.
Regulatory Status and Availability
The EMA’s CHMP issued its positive opinion on October 16, 2025. https://www.ema.europa.eu/medicines/human/scientific-advice-and-marketing-authorisation/human-medicines-under-evaluation This recommendation will now be forwarded to the European Commission for a final decision, which is expected in the coming months. Insmed anticipates working with EU member states to ensure access for eligible patients starting in early 2026.
Beyond Europe, brensocatib is currently under review by:
* Medicines and Healthcare products Regulatory Agency (MHRA) – United Kingdom: Application currently being assessed.
* Pharmaceuticals and Medical Devices Agency (PMDA) – Japan: Application currently being assessed.
Clinical Evidence Supporting brensocatib
The approval is based on data from clinical trials,including the Phase 3 TRUST-1 and TRUST-2 studies. These trials demonstrated that brensocatib significantly reduced the frequency of pulmonary exacerbations (flare-ups) in patients with NCFB. https://www.insmed.com/news-releases/insmed-announces-topline-results-from-phase-3-trust-2-trial-of-brensocatib-in-patients-with-non-cystic-fibrosis-bronchiectasis/
Key takeaways
* Brensocatib (BRINSUPRI) has received a positive CHMP opinion for the treatment of NCFB in
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